Pre-Administration of Brimonidine in Intravitreal Anti-VEGF Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-15

Study Completion Date

2017-09-01

Brief Summary

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In this study, investigators will be examining the intraocular pressure lowering effect of brimonidine 0.15% when administered 20min prior to intravitreal anti-VEGF injection.

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Detailed Description

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A total of 55 consecutive patients undergoing anti-VEGF intravitreal injections (received ≥1 treatments) for age-related macular degeneration (AMD), diabetic macular edema (DME) or macula edema secondary to branch retinal vein occlusion (BRVO) will be prospectively recruited between December 2016 and July 2017. Patients will be randomly assigned based on a pre-determined allocation sequence to receive topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) during either the first or second of two consecutive visits. A standard protocol for sterile preparation with topical 5% povidone-iodine solution will be followed. Pre-injection IOP measurements will be recorded prior to the instillation of dilating agents and brimonidine tartrate. A total of three IOP measurements will be taken by certified ophthalmic technicians at immediately after the injection (T0), 10 minutes after (T10) and 20 minutes after (T20) injection.

Conditions

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Post-Injection Intraocular Pressure Spikes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Brimonidine Pre-Administration During First Visit

Group Type ACTIVE_COMPARATOR

topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)

Intervention Type DRUG

The rapid hypotensive effects of topical alpha2-agonists such as brimonidine tartrate on decreasing aqueous production and increasing uveoscleral outflow, in addition to their neuroprotective properties, make them an attractive option for prophylactic treatment of post-injection IOP spikes.

Brimonidine Pre-Administration During Second Visit

Group Type ACTIVE_COMPARATOR

topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)

Intervention Type DRUG

The rapid hypotensive effects of topical alpha2-agonists such as brimonidine tartrate on decreasing aqueous production and increasing uveoscleral outflow, in addition to their neuroprotective properties, make them an attractive option for prophylactic treatment of post-injection IOP spikes.

Interventions

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topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)

The rapid hypotensive effects of topical alpha2-agonists such as brimonidine tartrate on decreasing aqueous production and increasing uveoscleral outflow, in addition to their neuroprotective properties, make them an attractive option for prophylactic treatment of post-injection IOP spikes.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* received ≥1 treatments for age-related macular degeneration (AMD), diabetic macular edema (DME) or macula edema secondary to branch retinal vein occlusion (BRVO)

Exclusion Criteria

* baseline diagnosis of glaucoma
* baseline IOP during last visit of greater than 21 mmHg
* ongoing use of topical medications (eg. corticosteroids)
* pseudophakic with an anterior chamber intraocular lens
* history of ocular conditions that may impact IOP (eg. pseudoexfoliation)
* previous in-office (eg. laser peripheral iridotomy) and vitreoretinal surgical procedures (eg. pars plana vitrectomy).

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes